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Protocol Details

Pilot Study of the Use of Functional Near-Infrared Spectroscopy (fNIRS) Combined with Diffuse Correlation Spectroscopy (DCS) in Neurocognitive Disease as Compared to Healthy Neurotypical Controls

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000862-CH

Sponsoring Institute

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 6 mo
Max Age: 110 Years

Referral Letter Required

No

Population Exclusion(s)

Non-English Speaking

Keywords

Brain Hypometabolism;
Cerebral Blood Flow;
Portable Brain Imaging;
Cerebral O2 Changes;
Neurocognitive Disorders;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Juvenile Neuronal Ceroid Lipofuscinosis;
Smith-Lemli-Opitz Syndrome;
Creatine Transporter Deficiency;
Niemann-Pick Disease Type C1

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Child Health and Human Development

Background:

Neurocognitive disorders affect how the brain uses oxygen. They may affect mental development in children. These disorders can be studied with imaging scans that use radiation; however, these methods are not ideal for research on children. Two technologies-functional near-infrared spectroscopy (fNIRS) and diffuse correlation spectroscopy (DCS)-use light to detect changes in brain activity. These methods are safer, and they can be used in a more relaxed setting. In this natural history study, researchers want to find out whether fNIRS and DCS can be a good way to study people with neurocognitive disorders.

Objective:

To find out whether fNIRS and DCS can be useful in measuring brain activity in people with neurocognitive disorders.

Eligibility:

People aged 6 months or older with neurocognitive disorders. These can include Niemann-Pick disease type C1 (NPC1); creatine transporter deficiency (CTD); Smith Lemli Opitz syndrome (SLOS); juvenile neuronal ceroid lipofuscinosis (CLN3 disease); and Pheland-McDermid (PMS) syndrome. Healthy volunteers are also needed.

Design:

Participants will have a physical exam. They will have tests of their memory and thinking.

Participants will sit in a quiet room for the fNIRS and DCS tests. A snug cap (like a cloth swim cap) will be placed on their head. The cap has lights and sensors. Another sensor will be placed on their forehead. Participants will perform tasks on a computer. This testing will take 45 to 60 minutes.

The tests will be repeated within 1 to 4 weeks. Participants will be asked to return for repeat tests 1 year later.

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Eligibility

INCLUSION CRITERIA:

-For both study populations (Affected and Typically Developing group):

--Male or female, aged 6 months and up

--English is the primary language spoken at home

-For study population (Affected group):

--Neurocognitive-related conditions including SLOS, CLN3, CTD, NPC and PMS.

-For controls (Typically Developing Group):

--In good general health as determined by medical history and physical exam

EXCLUSION CRITERIA:

-For both study populations (Affected and Typically Developing group):

--Any condition that may affect placement of the fNIRS-DCS

--Past or present vascular disease

--Traumatic loss of consciousness in the last year

--Any condition which, in the opinion of the investigator, increases risk of participation or affects adherence to the protocol

-For controls (Typically Developing Group):

--Known or suspected cognitive impairment

--Known history of MRI abnormality

--Current use of psychotropic medications


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Samar N. Rahhal, M.D.
National Institute of Child Health and Human Development (NICHD)
NIHBC 10 - CRC BG RM 2-5132
10 CENTER DR
BETHESDA MD 20892
(202) 468-1716
rahhalsn@nih.gov

Samar N. Rahhal, M.D.
National Institute of Child Health and Human Development (NICHD)
NIHBC 10 - CRC BG RM 2-5132
10 CENTER DR
BETHESDA MD 20892
(202) 468-1716
rahhalsn@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT05642221

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